The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Cyber Ho.
Device ID | K170331 |
510k Number | K170331 |
Device Name: | Cyber Ho |
Classification | Powered Laser Surgical Instrument |
Applicant | quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
Contact | Francesco Dell'antonio |
Correspondent | Francesco Dell'antonio quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-02 |
Decision Date | 2017-03-03 |
Summary: | summary |